EMD THERMOGRAPHY SYSTEM— 510(k) K050239

Substantially Equivalent

Em Diagnostics, Inc.

FDA 510(k) clearance K050239 for EMD THERMOGRAPHY SYSTEM, Substantially Equivalent on 2006-03-16. Applicant: Em Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Em Diagnostics, Inc.
Product code: Code LHQ
Device class: Class 1
Regulation: 21 CFR 884.2980
Advisory panel: Obstetrics/Gynecology
Date received: 2005-02-02
Decision date: 2006-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stamford, CT, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.